MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED STEMMED TIBIAL TRAY LEFT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that while the surgeon was performing a left knee arthroplasty, the left knee tibial tray was opened.The outer and inner label were confirmed to be identical and there were no difficulties implanting the tibial tray.However, upon having difficulty seating the left articular surface, it was identified that the etch on the tibial tray was for a right knee, rather than a left knee.As there were no issues with the fit of the tibial tray and the cement had already cured, the surgeon opted to leave the right tibial tray in the knee and a right articular surface was used to complete the procedure.The patient has since experienced no post-operative complications and the surgeon does not plan to revise the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of provided pictures, which identified that a right tibial tray was implanted into the patient's left knee.The provided picture also shows that the box in which the device was packaged, is labeled for a left knee.As the device was not able to be returned, further evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Products were reviewed for compatibility and it was noted that the left femur which was implanted, is not compatible with the right tibial tray and articular surface.Radiographs were provided, however they were not reviewed by a third party as it was determined it would not enhance the investigation.The root cause of the reported issue is attributed to manufacturing error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b1, b2, b4, b5, b7, d6a, g3, g6, h2, h6, h11.Additional medical records received were reviewed that further confirmed the reported event.The root cause remains attributed to the previously reported manufacturing issue.
Event or Problem Description
It was reported that while the surgeon was performing a left knee arthroplasty, the left knee tibial tray was opened.The outer and inner label were confirmed to be identical and there were no difficulties implanting the tibial tray.However, upon having difficulty seating the left articular surface, it was identified that the etch on the tibial tray was for a right knee, rather than a left knee.As there were no issues with the fit of the tibial tray and the cement had already cured, the surgeon opted to leave the right tibial tray in the knee and a right articular surface was used to complete the procedure.It was additionally reported that the patient has since experienced unknown complications and is being recommended for a knee arthroplasty revision approximately two (2) years post-operatively.Initial operative notes confirm that when the surgeon encountered difficulty implanting the articular surface, the tibial tray was confirmed to be etched for a right knee.After removing excess cement and irrigating the joint, the surgical team elected to proceed with placement of a matching right-sided polyethylene liner.The implant achieved satisfactory range of motion with appropriate varus/valgus and flexion/extension balance.No additional intraoperative complications were noted.

• Brand Name: PERSONA CEMENTED STEMMED TIBIAL TRAY LEFT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18344396
• Report Number: 3007963827-2023-00340
• Device Sequence Number: 6212553
• Product Code: JWH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)311122(10)65284815
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007501
• Device Lot Number: 65284815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 04/02/2024; 11/06/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/04/2024; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male